CancerPhase 2NCT02159482
Pilot Study of Interferon Alfa for Patients Who Have Received Cancer Vaccines
A Phase 2 study testing Interferon Alfa-2a in people with Cancer, run by Duke University.
Trial summary
This research study is for people who have previously received cancer vaccines. The investigators are testing a form of therapy known as interferon alfa-2a, which is commercially available as the drug Roferon®-A, to see if it can be used to help boost the effects of the cancer vaccine and help the immune system attack… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Interferon Alfa-2a
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have received a cancer vaccine targeting tumor antigen.
- 6 months following the last dose of the prior vaccine.
- Measurable disease defined by the RECIST criteria (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT.)
- Karnofsky performance status greater than or equal to 70%
- Estimated life expectancy > 6 months.
- Age ≥ 18 years.
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- Adequate, hematologic function with:
- WBC ≥ 3000 mm3
- hemoglobin ≥ 9 mg/dL (may transfuse or use erythropoietin to achieve this level)
- platelets ≥ 100,000/mm3
- Adequate, renal and hepatic function with:
- serum creatinine < 2.5 mg/dL
- bilirubin < 2.0 mg/dL
- SGOT/SGPT < 1.5 x upper limit of normal
- No prior grade 3 or 4 major organ or allergic toxicity attributable to the prior vaccine
- Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
- Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol.
Who cannot join
- Patients with concurrent chemotherapy, radiation therapy, or immunotherapy should be excluded. Patients may not have received interferon previously.
- Patients with either previously irradiated or new CNS (central nervous system) metastases at entry are excluded. Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms.
- Patients with a history of auto-immune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Patients with serious intercurrent chronic or acute illness, such as cardiac disease, (NYHA class III or IV), hepatic disease, or other illness considered by the PI as unwarranted high risk for investigational drug treatment.
- Patients with a medical or psychological impediment to probable compliance with the protocol.
- Concurrent second malignancy other than non-melanoma skin cancer, or controlled superficial bladder cancer.
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- Presence of an active acute or chronic infection including: an urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). HIV patients are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
- Patients on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.
- Patients with egg allergies or allergies to any component of the vaccine should be excluded from the protocol.
- Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control in order to be in this study. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that maybe fathered while on this study.
About this study
This research study is for people who have previously received cancer vaccines. The investigators are testing a form of therapy known as interferon alfa-2a, which is commercially available as the drug Roferon®-A, to see if it can be used to help boost the effects of the cancer vaccine and help the immune system attack the cancer.
It is believed that the body's immune system can attack tumor cells and kill them. This is thought to be due to immune cells called T cells which can recognize special proteins on the surface of tumors as a signal to fight the cancer. However, the vaccine may not work very well if the protein signal is too weak for the T cells to find your tumors. The investigators think that interferon alfa-2a can signal the cancer cells in the body to make more proteins that may allow the T cells to recognize and kill the cancer cells better.
- Conditions
- Cancer
- Being tested
- Interferon Alfa-2a
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Alfa-2aDrug
Also called Roferon®-A
| Study group | Role | What they receive |
|---|---|---|
| interferon-alfa-2a | Experimental | Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. Receives: Drug: Interferon Alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Clinical Responders (Complete Response + Partial Response)
Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks.
Measured: 4 weeks
Secondary outcomes (1)
Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response
The proportion of patients experiencing an increase in the magnitude of the tumor antigen-specific immune response following the administration of interferon will also be estimated. Immune response will be determined by ELISPOT analysis.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startNov 2005
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Morse, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159482
- Sponsor's protocol ID
- Pro00014489
- Status last verified
- Jun 2014
- First submitted
- 6 Jun 2014
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Interferon Alfa for Patients Who Have Received Cancer Vaccines
- ClinicalTrials.gov ID
- NCT02159482
- Acronym / sponsor ID
- Pro00014489
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Posted 16 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is for people who have previously received cancer vaccines. The investigators are testing a form of therapy known as interferon alfa-2a, which is commercially available as the drug Roferon®-A, to see if it can be used to help boost the effects of the cancer vaccine and help the immune system attack the cancer.
It is believed that the body's immune system can attack tumor cells and kill them. This is thought to be due to immune cells called T cells which can recognize special proteins on the surface of tumors as a signal to fight the cancer. However, the vaccine may not work very well if the protein signal is too weak for the T cells to find your tumors. The investigators think that interferon alfa-2a can signal the cancer cells in the body to make more proteins that may allow the T cells to recognize and kill the cancer cells better.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interferon-alfa-2a | Experimental | Drug: Interferon Alfa-2aStarting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Must have received a cancer vaccine targeting tumor antigen.
- 6 months following the last dose of the prior vaccine.
- Measurable disease defined by the RECIST criteria (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT.)
- Karnofsky performance status greater than or equal to 70%
- Estimated life expectancy > 6 months.
Key exclusion criteria (10 listed)
- Patients with concurrent chemotherapy, radiation therapy, or immunotherapy should be excluded. Patients may not have received interferon previously.
- Patients with either previously irradiated or new CNS (central nervous system) metastases at entry are excluded. Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms.
- Patients with a history of auto-immune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Patients with serious intercurrent chronic or acute illness, such as cardiac disease, (NYHA class III or IV), hepatic disease, or other illness considered by the PI as unwarranted high risk for investigational drug treatment.
- Patients with a medical or psychological impediment to probable compliance with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Alfa-2aAlso: Roferon®-A | Drug | interferon-alfa-2a |
Primary outcome
Proportion of Clinical Responders (Complete Response + Partial Response)
Time frame: 4 weeks
Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks.
1 secondary outcome
Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Morse, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon Alfa-2a in people with Cancer, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Clinical Responders (Complete Response + Partial Response) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.